What this study is
The study will examine a 10-week resistance training program, with or without creatine monohydrate supplementation, in adult survivors of head and neck cancer. Participants will undergo screening and complete study assessments before and after the training period and at a follow-up evaluation. The study will evaluate feasibility, safety, body composition, physical function, cancer-related fatigue, quality of life, and symptom burden in this population.
What's being tested
- Creatine Supplementation
Intervention · DIETARY SUPPLEMENT
Creatine monohydrate: 0.3g/kg x 7 days as loading dose followed by 0.1g/kg for the remainder of the study
- Resistance Training
Intervention · OTHER
Resistance training: 3 sessions per week (30 sessions total), hybrid format (in-person and telehealth), 45-60 minutes, followed progressive resistance training protocol, 1:1, supervised. Each session has three components (warm up, primary workout, cool-down phase)
Study details
- Official title
- Pilot Randomized Trial Evaluating Resistance Exercise Training and Creatine Supplementation in Individuals Treated for Head and Neck Cancer
- Sponsor
- Medical University of South Carolina
- Conditions
- Head and Neck Cancer · Cancer Survivorship · Treatment-related Muscle Loss · Physical Function
- Enrolling
- 30 people
- Starts
- 2026-11-15
- Est. completion
- 2029-09-15
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 18 years or older.
- Diagnosis of head and neck cancer (AJCC stages I-IV).
- Completed curative-intent primary treatment, including surgery, radiation, chemotherapy, or combination treatment, within the past 1 to 3 months.
- Clearance to engage in moderate-intensity exercise based on the American College of Sports Medicine (ACSM) Preparticipation Screening Guidelines.
- Willingness and ability to participate in both in-person and/or virtual supervised exercise sessions.
- Willingness to adhere to the supplementation regimen throughout the study.
- English-speaking and able to understand study instructions and complete questionnaires.
- Access to internet for remotely supervised exercise sessions.
- Availability for the full 10-week intervention and post-intervention assessments.
You can't join if
- Current participation in structured resistance training 2 or more days per week within the past 6 months.
- Cognitive, psychiatric, or neurologic conditions that would impair ability to consent or adhere to study procedures.
- Pre-existing renal impairment.
- Current use of creatine supplements, defined as consistently taking creatine more than 2 days per week for the past 6 months.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMedical University of South Carolina
Charleston, South Carolina, United States
- Brian Cence · Contact843-792-2668cence@musc.edu
Study team
Sponsor
Medical University of South Carolina
Study ID Pro00148118
Principal investigator
Chris Gregory, PhD, PT
Medical University of South Carolina
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.